Chronic prostatitis is a disabling condition of unknown origin affecting men of all ages and ethnic groups. Most have chronic pelvic pain associated with urinary frequency and urgency; however, they do not have demonstrable urinary or prostatic infections that can be detected by conventional microbiological techniques. In response to the growing concerns about the diagnosis and treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), the Chronic Prostatitis Collaborative Research Network (CPCRN), which consists of six clinical centers and one data coordinating center, was established to study this syndrome in order to improve diagnosis and treatment.
The CPCRN conducted a prospective observational cohort study designed to characterize CP/CPPS, examine symptoms and quality of life in affected men, and assess the economic impact of the condition. Men of any age with symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior were eligible for enrollment. The CPCRN cohort study consisted of a baseline screening phase and a longitudinal follow-up phase. During the baseline screening phase, eligibility criteria were assessed, and baseline data and biospecimens (including serum, prostatic fluid, and semen) were collected. Information on symptoms and quality of life, demographic and lifestyle factors, medical history, prior treatments and procedures, and health resource utilization was collected.
The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.
The primary objective of the study was to characterize CP/CPPS by examining the diagnosis, symptoms, and quality of life in affected men and assessing the economic impact of the condition.
Clinical and laboratory values from physical examination and laboratory studies, the NIH Chronic Prostatitis Symptom Index (NIH-CPSI), and quality of life assessments were used as outcome measures.
Participants included men of all ages who had experienced symptoms of discomfort or pain in the pelvic region for at least 3 of the 6 months prior to the baseline screening visit. Men who had used antimicrobial agents, had an active genitourinary infection, or a prostate biopsy within the past three months were deferred for 3 months, and at that time they were allowed to enter into the study.
Exclusion criteria are documented in the study protocol.
The study found that CP/CPPS is a multifactorial problem affecting men of all ages and demographics. The condition is characterized by substantial variation in symptoms within and among subjects. There is no evidence that the disorder worsens significantly during 2 years of follow-up, and for about a third of men with long-standing symptoms there may be moderate to marked improvement during this period. Men with chronic prostatitis experience impairment in the mental and physical domains of general health related quality of life, and many have benefited only minimally from empirical, goal-directed therapy. The CPCRN has conducted numerous clinical trials to investigate the safety and efficacy of numerous treatments for CP/CPPS, for which more details are available on the NIDDK Repository website.
Urologic Diseases
Observational
6
Prostatitis
Pelvic Pain, Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Prostatic Disease, Chronic Prostatitis, NIH Chronic Prostatitis Symptom Index (NIH-CPSI), Urogenital Disease
Division of Kidney, Urologic, and Hematologic Diseases
Document Name | Description | Document Type | File Format | Compliance | Download |
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Document Name | Description | Document Type | File Format |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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Patient Withdrawal Form Dataset | Contains data from the Patient Withdrawal Form | 149 | sas7bdat (17 KB); csv (6.4 KB) | |
Serum Sample Form Dataset | Contains data from the Serum Sample Form | 487 | sas7bdat (41 KB); csv (26.2 KB) | |
Four Glass Test Specimen Cultures Form Dataset | Contains data from the Four Glass Test Specimen Cultures Form | 1106 | sas7bdat (193 KB); csv (96.49 KB) | |
Four Glass Test Specimen Cultures Form - 07a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 07a | 1308 | sas7bdat (81 KB); csv (31.25 KB) | |
Semen Sample Form - 09a Dataset | Contains data from the Semen Sample Form - 09a | 697 | sas7bdat (49 KB); csv (16.63 KB) | |
Four Glass Test Specimen Cultures Form - 10a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 10a | 1175 | sas7bdat (73 KB); csv (27.99 KB) | |
Medical History Form Dataset | Contains data from the Medical History Form | 488 | sas7bdat (273 KB); csv (83.91 KB) | |
Resource Utilization Survey Form - 07 Dataset | Contains data from the Resource Utilization Survey Form - 07 | 16 | sas7bdat (9 KB); csv (434 B) | |
Screening Confirmation Form Dataset | Contains data from the Screening Confirmation Form | 488 | sas7bdat (49 KB); csv (37.27 KB) | |
Resource Utilization Survey Form - 05 Dataset | Contains data from the Resource Utilization Survey Form - 05 | 258 | sas7bdat (25 KB); csv (8.42 KB) | |
Epidemiologic History Form Dataset | Contains data from the Epidemiologic History Form | 487 | sas7bdat (248 KB); csv (68.08 KB) | |
Symptom Index Dataset | Contains data from the Symptom Index | 5338 | sas7bdat (1.38 MB); csv (493.86 KB) | |
Semen Sample Form Dataset | Contains data from the Semen Sample Form | 487 | sas7bdat (73 KB); csv (41.96 KB) | |
Four Glass Test Specimen Cultures Form - 02a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 02a | 1584 | sas7bdat (97 KB); csv (38.1 KB) | |
Prior Treatments and Procedures Form Dataset | Contains data from the Prior Treatments and Procedures Form | 488 | sas7bdat (145 KB); csv (45.2 KB) | |
Concomitant Medications Form Dataset | Contains data from the Concomitant Medications Form | 486 | sas7bdat (61 KB); csv (27.18 KB) | |
Urethral Swab Form Dataset | Contains data from the Urethral Swab Form | 485 | sas7bdat (41 KB); csv (25.62 KB) | |
Baseline Dataset | A summary analysis data file for all data collected at baseline | 488 | sas7bdat (5.26 MB); csv (1.27 MB) | |
Four Glass Test Specimen Cultures Form - 14a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 14a | 1380 | sas7bdat (81 KB); csv (32.98 KB) | |
Voiding Log Form Dataset | Contains data from the Voiding Log Form | 1126 | sas7bdat (169 KB); csv (100.13 KB) | |
Analysis Dataset | A summary analysis data file for all data collected for the "CPC Control Group Study" Ancillary study | 584 | sas7bdat (6.32 MB); csv (1.63 MB) | |
Uroflow Study Form Dataset | Contains data from the Uroflow Study Form | 488 | sas7bdat (49 KB); csv (26.37 KB) | |
Semen Sample Form - 07a Dataset | Contains data from the Semen Sample Form - 07a | 644 | sas7bdat (41 KB); csv (15.35 KB) | |
Resource Utilization Survey Form - 03 Dataset | Contains data from the Resource Utilization Survey Form - 03 | 21 | sas7bdat (9 KB); csv (526 B) | |
Patient Reinstatement Form Dataset | Contains data from the Patient Reinstatement Form | sas7bdat (9 KB); csv (59 B) | ||
Physical Exam Form Dataset | Contains data from the Physical Exam Form | 1831 | sas7bdat (561 KB); csv (207.96 KB) | |
Four Glass Test Specimen Cultures Form - 05a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 05a | 1139 | sas7bdat (73 KB); csv (28.08 KB) | |
Deferral Checklist Form Dataset | Contains data from the Deferral Checklist Form | 488 | sas7bdat (73 KB); csv (30.17 KB) | |
Four Glass Test Microscopy Dataset | Contains data from the Four Glass Test Microscopy | 1835 | sas7bdat (561 KB); csv (198.59 KB) | |
Exclusion Checklist Form Dataset | Contains data from the Exclusion Checklist Form | 488 | sas7bdat (73 KB); csv (30.18 KB) | |
Longitudinal Dataset | A summary analysis data file for all data collected during the longitudinal study phase | 6675 | sas7bdat (20.95 MB); csv (7.24 MB) | |
Resource Utilization Survey Form Log Dataset | Contains data from the Resource Utilization Survey Form Log | 167 | sas7bdat (33 KB); csv (26.77 KB) | |
Inclusion Checklist Form Dataset | Contains data from the Inclusion Checklist Form | 488 | sas7bdat (57 KB); csv (28.69 KB) | |
Four Glass Test Specimen Cultures Form - 09a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 09a | 1659 | sas7bdat (97 KB); csv (39.92 KB) | |
Patient Completion Form Dataset | Contains data from the Patient Completion Form | 276 | sas7bdat (33 KB); csv (21.61 KB) | |
Four Glass Test Specimen Cultures Form - 03a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 03a | 1116 | sas7bdat (65 KB); csv (26.57 KB) | |
Resource Utilization Survey Form - 010 Dataset | Contains data from the Resource Utilization Survey Form - 010 | 128 | sas7bdat (17 KB); csv (4.57 KB) | |
Four Glass Test Specimen Cultures Form - 12a Dataset | Contains data from the Four Glass Test Specimen Cultures Form - 12a | 1252 | sas7bdat (73 KB); csv (30.84 KB) | |
Interim Health Care Form Dataset | Contains data from the Interim Health Care Form | 1497 | sas7bdat (529 KB); csv (175.05 KB) |